COATS ALOE- allantoin lotion 
TYCHASIS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COATS ALOE LOTION

Active Ingredient:

Allantoin 0.5%

Purpose:

Skin Protectant.

Warnings:

For external use only.

Do not get into eyes.

Stop use if:

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.

Uses:

Temporarily protects minor:

Helps prevent and temporarily protects and helps relieve chaffed, chapped, or cracked skin.

Helps prevent and protect from the drying effects of wind and cold weather.

Caution:

Do not use on deep puncture wounds, animal bites, serious burns.

Keep out of reach of children:

If swallowed get medical help or contact a poison control center right away.

Directions:

Apply as needed.

Inactive Ingredients:

aloe barbanesis leaf juice, ethylhexyl palmitate, glycerin, methylgluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolomine, stearic acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

Questions:

Toll free 888-650-0040

Package label COATS ALOE LOTION

COATS ALOE LOTION 8 OZ

COATS ALOE 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LAURETH-4 (UNII: 6HQ855798J)  
LAURETH-23 (UNII: N72LMW566G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BOROGLYCERIN (UNII: U3LMU4AN21)  
Product Characteristics
Colorwhite (may be slightly off white due to natural variations of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70211-702-0259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
2NDC:70211-702-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
3NDC:70211-702-33976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/02/2015
Labeler - TYCHASIS CORPORATION (022731149)
Registrant - TYCHASIS CORPORATION (022731149)
Establishment
NameAddressID/FEIBusiness Operations
BIOMED LABORATORIES055329696manufacture(70211-702)

Revised: 1/2023
Document Id: f18f35fc-91a0-c061-e053-2a95a90a2e48
Set id: 23939910-3d59-5ffb-e054-00144ff8d46c
Version: 3
Effective Time: 20230105
 
TYCHASIS CORPORATION